ORCA Foam

Basic Information

• Brand Name: ORCA Foam
• Primary DI: 10860003109974
• Version / Model: Size 12/7
• Company Name: Orca Products, LLC
• Labeler DUNS: 117716283
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-02-24
• Public Version: 3
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 8e55058e-4f1b-4d5a-83a0-49859b1beb57
• Distribution End Date: 2023-09-01

Device Description

AbsorbaleGelatin Sponge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	874.4780	1
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48170	Gelatin haemostatic agent	A sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00860003109977	GS1
Primary	10860003109974	GS1

Premarket Submissions

Submission Number	Supplement Number
K060878	000